Stakeholders Support Legislation That Will Stop Brand Drug Companies From Blocking Access to Affordable Generic Drugs
WASHINGTON, DC (April 27, 2017) – The Association for Accessible Medicines (AAM) and its Biosimilars Council wholeheartedly support bipartisan legislation introduced in the House and Senate today to increase competition for prescription drugs and lower the cost of treatments for patients in the U.S.
The National Health Council Supports Generic Drugs as a Way to Reduce Health Care Costs
WASHINGTON, DC (April 27, 2017) – The Association for Accessible Medicines (AAM) today applauded the National Health Council (NHC) for supporting polices to reduce patient health care costs and increase patient access to affordable medicines by expediting the approval of generic applications and stopping brand drug companies from abusing REMS programs.
Under the Food and Drug Administration Amendments Act (FDAAA) of 2007, FDA can require manufacturers of drugs with known risks to develop a Risk Evaluation and Mitigation Strategies (REMS) program. REMS programs are designed to ensure that the benefits of a drug or biologic outweigh its risks to enable patients to have continued access to these medicines. The manufacturer of the drug develops the REMS program, which the FDA then reviews and approves.
April 6, 2017
The Honorable David McKinley
The Honorable Peter Welch
Dear Congressmen McKinley and Welch:
As stakeholders firmly committed to fostering patient access to affordable medicines and pharmaceutical competition, we would like to thank you for introducing the Fair Access for Safe and Timely (“FAST”) Generics Act. The bill would provide a clear solution to abusive, anticompetitive business practices that increase costs to the American health care system by impeding patient access to generic and biosimilar medicines.